IntelGenx Corp., a leading drug delivery company, announced United States Patent and Trademark Office (USPTO) has granted a patent protecting Rizaport, an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines. This patent protects the composition of Rizaport and will be listed in the Orange Book upon approval of the product by the FDA.
The patent application, entitled "Instantly Wettable Oral Film Dosage Form Without Surfactant or Polyalcohol" covers rapidly disintegrating film oral dosage forms and is expected to be valid until 2034 once granted.
"Rizaport is the first patent allowed for an oral film for the treatment of migraine," said Dr. Horst G. Zerbe, president and CEO of IntelGenx. "We are committed to bringing Rizaport to market as soon as possible as we believe it will be a beneficial treatment for patients suffering from migraines. The patent allowance is one more systematic step towards strengthening our patent portfolio supporting IntelGenx's proprietary VersaFilm technology. This will now further enable IntelGenx to accelerate our ongoing partnering efforts in the USA and abroad."
Rizaport was granted marketing authorisation in November 2015 from the Federal Institute for Drugs and Medical Devices of Germany (BfArM). The worldwide migraine market is expected to exceed $2 billion in sales in 20161. Rizaport is the first oral thin film bioequivalent to Maxalt Lingua. The Rizaport oral thin film has a pleasant taste and dissolves rapidly in the mouth, without the need for water. It is a therapeutic alternative for patients suffering from dysphagia (difficulty swallowing), and patients who suffer from migraine-related nausea, estimated to be approximately 80 per cent of the total migraine patient population. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms.
IntelGenx and its co-development partner, RedHill Biopharma Ltd. submitted a New Drug Application (NDA) to the FDA in 2013 seeking marketing approval of Rizaport in the US. In 2014, the companies received a Complete Response Letter (CRL) from the FDA which raised questions primarily related to CMC. It is noted that no deficiency was raised relating to the safety or bio-equivalence data of Rizaport. IntelGenx and RedHill reported that they believe that FDA approval of the Rizaport NDA is subject to the satisfactory resolution of the remaining CMC questions. IntelGenx and RedHill continue their cooperative effort to work with the FDA in order to address and resolve all remaining CMC questions and to secure a compliant source of the raw material.
Rizaport is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt. Rizaport 5mg and 10mg was approved for marketing in Germany in October 2015, under the European Decentralized Procedure. A New Drug Application for Rizaport was also filed with the US FDA in 2013 and a CRL was received in 2014. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $870 million in 2014. Rizaport is based on IntelGenx's proprietary "VersaFilm" technology. It dissolves rapidly and releases its active ingredient in the mouth, leading to efficient absorption of the drug through the gastrointestinal tract. The administration method of the Rizaport oral thin film, which does not require the patient to swallow a pill or consume water, along with its pleasant flavor, presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated to be approximately 80 per cent of the total migraine patient population.